EXHIBIT U – User Manual FCC ID# NMEAVTS1000
DATA CRITICAL CORP.
Precautionary Information Caution Instructions - For continued safe use of this equipment, it is necessary that the listed instructions be followed. However, instructions listed in this manual in no way supersede established medical procedures concerning patient care. Intended Use - The system is intended to monitor various patientmonitoring devices for alarm conditions, and responds by transmitting message data that includes text information from the patient.
Warnings ! Patient Monitoring - The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Patient alarm conditions and notifications are primary functions of the patient monitoring system. It is imperative that the caregiver and/or monitoring floor technicians monitor patient alarm conditions. The AlarmView System is not intended for use as the primary source for the patient alarm notification.
Environment - Data Critical Corporation does not assume responsibility for damage to the equipment caused by improperly vented cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on such walls. Explosion Hazard - Do not use this equipment in the presence of flammable anesthetics, skin cleaning agents, and disinfectants. Great care must be exercised when the device is used in an oxygen-enriched atmosphere.
Indications for Use This device is intended for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. AlarmView is limited to use by qualified medical professionals who have been trained on the use of the device.
For devices not listed in the above compatibility chart, a separation distance of 5.5 feet between the AlarmView Transmitter and other emitting devices should be observed. For the devices listed on the above compatibility chart, the AlarmView Transmitter may be placed in either of the configurations described below: • • The AlarmView transmitter can be located remotely from the patient device (e.g. place the AlarmView Transmitter on the wall instead of the patient monitoring equipment).
Alarm Data The alarm data that the AlarmView system echoes are listed in the following chart.
It should be emphasized that this alarm data is passed to AlarmView via simple text strings. No interpretation of this information is made. Whatever the monitor passes AlarmView is what will be passed through and transmitted to the nurse. Also, these alarm modes are determined by the protocols we are claiming compatibility with: N-x9y and N-3000.
Conventions of this Manual Two items that may help you as you work through the AlarmView User’s Guide are the special notes and cautions that appear throughout this text. Individual icons identify these notes and cautions, and they alert you to special information. NOTE The Caution icon alerts you to possible problems that you may encounter as you work through the AlarmView™ System programs. The possibility of losing data, for example, is information that could be mentioned in a caution.
Introduction AlarmView™ System Product Description The AlarmView System is a secondary alarm notification system that transmits alarm data from Primary Patient Monitoring Equipment (PME) to pagers that are worn by caregivers. • The AlarmView Pager - The AlarmView Pager is an off the shelf pager that is worn by caregivers responsible for individual patient care.
AlarmView System Diagram
AlarmView™ System System Components Transmitter The transmitter is Data Critical Corporation’s proprietary RF transmitter operating in the UHF band (450-466MHz). It has an a BNC connector for the antenna needed for the RF transmissions, an IR port used for setup, a button for power on/off and certain user initiated transmissions, and an RJ-45 connector for connection with the Patient Monitoring Equipment.
Monitoring Device Types The AlarmView software is currently configured to be compatible with Nellcor Puritan Bennett Pulse Oximeters N-290, N-295, or N-3000. Getting Started Before turning on the transmitter, ensure that the antenna is attached to the transmitter. The antenna is attached to the transmitter via a BNC connector found on the back of the transmitter (directly behind the LED). The power cable is attached on the back of the transmitter to the far right.
Pages sent during the Survey Mode will have a line of data, which will indicate that the Survey Mode is in process. Pages sent during the Survey Mode will contain the following data: Bed Number Transmission Number (in sequence) Programming Mode The Programming Mode is the mode in which the PDA is used to change or view the current setup (i.e. the bed number and the pager cap codes) of the transmitter.
The Editor Program Turn the PDA “ON”. The first screen of the PDA will appear and will resemble the screen below. Select the Windows Start menu button. From the Windows Start menu, select the “AV System Manager” program.
The AlarmView System Manager main screen will appear as shown below.
Tap the About button for information about the System Manager software. Tap the OK Button to return from this dialog box.
Now tap the Editor Button on the Main Screen. The following warning will appear. Pressing the “No Button” will return the user to the AlarmView System Manager main screen. Pressing the “Yes Button” will launch the “AlarmView Editor” program. This is the program used to setup which bed number and cap codes are present in the system. It can be reconfigured when pagers are sent back to the factory, or new pagers are obtained.
To configure the bed numbers available in the system, tap the Bed Numbers 1 - 24 tab or the Bed Numbers 24 – 48 tab. The first tab lists the first 24 bed numbers available to the system. The second tab lists the last 24 bed numbers available to the system. It is not necessary to fill in all 48 slots. Below is the Bed Numbers 1 – 24 screen.
Below is the Bed Numbers 24 – 48 screen. Note that the “active” tab is displayed in all caps.
Bed Numbers can be added and deleted from this list. Click on a bed number to edit. Using the stylus, tap the backspace key on the keyboard to delete the bed number to be edited (or highlight the entire bed number as shown below), and using the numbers and letters on the key board, type in the new bed number. Tap the “Save” button on completion, or the “Exit” button to exit the Editor Program.
If the key board is not visible, tap the keyboard icon to display the keyboard. If an additional bed number is desired, a bed number can be added to any blank space on page one or two of the bed number listing. Simply tap the cursor in the blank space and begin typing the new bed number. To edit the pager numbers, tap the “Pagers” tab on the upper right of the screen. The “AlarmView Editor” Screen Pagers page will appear.
Pager Cap Codes can be added and deleted from this list. Click on a cap code number to edit. Using the stylus, tap the backspace key on the keyboard to delete the cap code number to be edited (or highlight the entire cap code number), and using the numbers and letters on the key board, type in the new cap code number. Tap the “Save” button on completion, or the “Exit” button to exit the Editor Program. If the key board is not visible, tap the keyboard icon to display the keyboard.
When the “Editor Program” is exited, the Main Screen is again displayed.
The Configuration Program If the main PDA screen is displayed, tap Windows Start menu button. From the Windows Start menu, select the “AV System Manager program.
The AlarmView System Manager main screen will appear as shown below.
To launch the Configuration Program, tap the Programming button. The “Configuration Program” Main Screen will appear. This program is used to change the transmitter’s setup of bed numbers, cap codes, alarm severity, and reminder page interval. It also displays information that can not be modified by the user.
To obtain the current configuration programmed into the transmitter, tap the “Download Configuration Button”. When this button is tapped, the PDA attempts to establish communications with the transmitter. If the IR port could not be accessed, the following dialog box will be displayed. Tap the OK button to close this dialog box and return to the Configuration Program main screen.
When “OK” is tapped on this dialog box, the Configuration Program main screen will be displayed with a status message informing the user of a “Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the “Download Configuration Button” again. While the transmitter is being queried, the Configuration Program main screen will be displayed with a status message informing the user of a “Loading Data” status. The PDA will be in this state for less than 2 seconds.
When the transmitter has been successfully queried, the Configuration program main screen will be displayed with a status message informing the user of a “Transmitter Data Loaded” status.
At this point, if the displayed data is correct, no changes need be made, and the user is done. Exit the Configuration Program by tapping the “X” in the upper right corner of the screen. If the data needs to be changed, the Patient Bed Number can be selected by tapping on the bed number drop down list, and highlighting the desired bed number. A maximum of two pagers can be selected by clicking the radio button next to the desired pager number.
Alarm Severity selections: Send All Alarms indicates that all alarms will be sent to the pagers regardless of the severity of the alarms. Only Critical Alarms indicates that only critical (high prioirty and medium priority) alarms will be sent to the pagers. Reminder interval indicates the time interval at which reminders will be sent after the original alarm has not been silenced. Tap the OK button when all changes have been made.
If no bed number was selected before the “Program” button was tapped, the following error dialog box will appear. If no cap code was selected before the “Program” button was tapped, the following error dialog box will appear. Exit both of the above dialog boxes by tapping the OK Button. After the above error conditions are rectified, tap the “Program Transmitter” button again. When this button is tapped, the PDA attempts to establish communications with the transmitter.
If the IR port could not be accessed, the following dialog box will be displayed. Tap the OK button to close this dialog box and return to the Configuration Program main screen.
When “OK” is tapped on this dialog box, the Configuration Program main screen will be displayed with a status message informing the user of a “Failed to Connect” status.
At this point, simply point the PDA at the transmitter, and tap the “Program Transmitter Button” again. While the transmitter is being queried, the Configuration Program main screen will be displayed with a status message informing the user of a “Programming” status. The PDA will be in this state for less than 2 seconds.
When the transmitter is successfully programmed, the Configuration Program main screen will be displayed with a status message informing the user of a “Programming Successful” status.
A “Programming Successful” page will also be sent to the newly selected pagers, displaying the newly selected bed number. Exit the “Configuration” program by tapping the “X” in the upper right corner of the screen. When the Configuration Program has been exited, the System Manager Program main screen will be displayed as shown: Exit this program by tapping the Exit Button in the upper left of the screen.
Communicating With Patient Monitoring Equipment Turn on the transmitter, as described above. Attach the serial cable to the RJ-45 port. Attach the other end of the cable to the patient monitoring equipment. The transmitter will automatically detect the monitor (assuming it is an N-3000, N-295, or N-290). Once communications have been established with the patient monitoring equipment, a page will be sent to the pager indicating this, and the LED will turn GREEN.
Turn on the transmitter, as described above, and establish communications with the patient monitoring equipment (the LED will be transmitter (but, do not hold it down). A “Test Page” will be sent indicating the current patient data (SPO2, and Pulse Rate). Note that Test Page Bed: xxxxx SPO2: xxx The transmitter can only be turned off if it is not communicating with the patient monitoring equipment (i.e. the LED is RED). To turn off the goes off.
Communications Not Established Turn on the transmitter, as described above. The transmitter should not be attached to any patient monitoring equipment as this point. The LED on the front of the transmitter will be ORANGE to indicate that the transmitter is attempting to establish communications with the patient monitoring equipment. After 10 seconds of no communications, a page will be sent indicating that no communications have been established.
Bed: xxxx Low Tx Battery Tx Shut down
Appendix A Electromagnetic Interference It is a known fact that electronic devices that emit radio frequencies may interfere with the operation of other electronic devices. This has become proliferation of intentional electronic radiators such as cellular phones, paging systems, walkie-talkies, and wireless network LANs. The critical are of special concern and incidents have been observed with apnea monitors, wheel chairs, and ventilators.
• • • • educating staff (nurses and doctors) to be aware of, and to recognize, potential EMI related problems conducting technical remedial action to eliminate EMI, such as shielding sharing relevant EMI/EMC information with others, especially in evaluation of new equipment purchases which may have emissions identifying critical areas where life-support devices are in use and restricting the use of personal communicators (cellular phones) in those critical care areas Purchase critical care devices that co
The AlarmView™ System has a transmit power level of up to 1 watt peak at a pre selected RF frequency between 450 MHz to 466 MHz Protection Distance Estimate Immunity of Medical Device of 2 V/meter 1 watt x ft xm x ft xm x ft xm
Appendix B Terms Glossary BNC Connector: A type of connector used with coaxial cables. The basic BNC connector is a male type mounted at each end of a cable. This connector has a center pin connected to the center cable conductor and a metal tube connected to the outer cable shield. A rotating ring outside the tube locks the cable to any female connector. This is the type of connector that the antenna uses to connect to the transmitter. IR Port: Infrared port.
